Powered by AliveCor's proprietary KAI 12L AI technology, the pocket-sized Kardia 12L ECG System was designed exclusively for healthcare settings to detect 35 cardiac determinations, including heart attack.
MOUNTAIN VIEW, Calif., Jan. 14, 2025 /PRNewswire/ -- AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, today announced new data published in Computing in Cardiology (CINC) demonstrating that its Kardia 12L ECG System—the world's first AI-powered, handheld 12-lead ECG system with a unique single-cable design—performs comparably to a standard hospital-grade ECG for detecting common morphological cardiac abnormalities, including heart attack. The data was also presented at the 2024 CINC Conference in October.
"AliveCor's Kardia 12L ECG System was born from our vision to leverage AI and revolutionize traditional ECG screening," said Dr. David E. Albert, founder and chief medical officer of AliveCor. "This landmark study provides compelling clinical evidence that our AI, paired with our device's reduced leadset, delivers results on par with the gold-standard ECG that are typically only available in hospital settings. These data reinforce our belief that more convenient, AI-powered technology like ours can democratize access to potentially life-saving heart data."
The pocket-sized Kardia 12L device and its AI (KAI 12L) were FDA-cleared in June 2024 and applicable Category III Current Procedural Terminology (CPT) codes went into effect on January 1st, 2025 (published in the 2025 CPT Code book). Using only a single cable with 5 electrodes to acquire 8 high-quality diagnostic bandwidth leads, the Kardia 12L ECG System combines the power of KAI 12L's AI technology and the Kardia 12L, to enable faster, easier detection of 35 cardiac determinations, including heart attacks. This unique, simplified design makes it possible for more healthcare providers in a wider range of settings, including primary care offices, urgent care clinics, employer clinics, and rural locations, to access and integrate 12-lead ECG data into cardiac care.
In the study, performance was assessed using the Area Under the Curve (AUC) and Precision-Recall (AUCPR) metrics, standard metrics for detecting clinical cardiac abnormalities. The results indicated that Kardia 12L ECG System (with its reduced leadset) performed comparably to the standard 12-lead ECG in detecting major morphology-related abnormalities, including bundle branch blocks (BBB) (right BBB, AUCPR = 0.96; left BBB, AUCPR = 0.93), ischemia (AUC > 0.97), and myocardial infarction (MI) (Old MI, AUCPR = 0.77; Acute MI, AUCPR = 0.45). Overall, the results indicate the Kardia 12L ECG System's ability to maintain robust diagnostic accuracy for most major morphology classes.
"The study surpassed our expectations, showing that the Kardia 12L System's AI performs comparably to a hospital-grade ECG," said Joel Xue, lead study author and research fellow at AliveCor. "ECGs are crucial for cardiac care but they remain cumbersome and not always accessible for patients and healthcare providers. Here we've shown that the Kardia 12L System can help overcome these challenges, achieving high clinical standards while simplifying screening with a reduced leadset and far improved portability."
| Morphology classes | Standard 12-lead | Kardia 12L System: Reduced lead [I, II, V2, V4 ] AUC. | ||
|---|---|---|---|---|
| AUC | AUCPR | AUC | PR | |
| RBBB (right bundle branch block) | 1.0 | .96 | 1.0 | .96 |
| LBBB (left bundle branch block) | 1.0 | .93 | 1.0 | .93 |
| LVH (left ventricular hypertrophy) | 0.98 | .74 | .97 | .65 |
| Old MI (old myocardial infarction) | 0.98 | .78 | .98 | .77 |
| Acute MI (acute myocardial infarction) | 0.99 | .45 | .99 | .45 |
| Pace | .98 | .86 | .98 | .86 |
| Normal | .96 | .92 | .96 | .91 |
About the Kardia 12L ECG System
Kardia 12L ECG System is battery-operated, weighs just 0.3 pounds and can fit in a pocket – making it significantly smaller, more portable and more convenient than conventional 12-lead ECG machines. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. Powered by KAI 12L - the building block for the next generation of AI-driven technologies in AliveCor's pipeline - the device requires minimal self-guided training and is simpler to use than standard 12-lead ECG machines. Its speed and simplicity assists healthcare providers in rapid disease detection and enhancing patient experience.
For healthcare providers interested in purchasing a Kardia 12L, please visit alivecor.com/products/kardia12L.
About AliveCor
AliveCor, Inc. is pioneering the creation of FDA-cleared ‘machine learning’ techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. The FDA-cleared Kardia Mobile is the most clinically validated mobile ECG solution on the market and is recommended by leading cardiologists and used by people worldwide for accurate ECG recordings. This simple-to-use mobile device and app-based service provides instant analysis for detecting atrial fibrillation (AF) and normal sinus rhythm in an ECG. Kardia Pro is the first AI-enabled platform for doctors to monitor patients for the early detection of atrial fibrillation, the the most common cardiac arrhythmia that leads to a five times greater risk of stroke. AliveCor was recognized by Fast Company as one of 2017’s most innovative companies in health (#3). AliveCor is a privately-held company headquartered in Mountain View, Calif. For more information, please visit alivecor.com.